Trial Phases

Question 1

FDA’s ________ is responsible for regulating vaccines in the US.

Answer 1

Center for Biologics Evaluation and Research (CBER).

Question 2

A sponsor, usually a private company, who wishes to begin clinical trials with a vaccine must submit an Investigational __________ to FDA, which describes the vaccine, its method of manufacture, and quality control tests for release.

Answer 2

New Drug application (IND)

Question 3

An __________, representing an institution where the clinical trial will be conducted, must approve the clinical protocol presented in an IND application. The FDA has 30 days to approve the application.

Answer 3

institutional review board (IRB)

Question 4

After a successful Phase 3 trial, the vaccine developer will submit a _______ to the FDA.

Then, the FDA will inspect the factory where the vaccine will be made and approve the labeling of the vaccine.

Answer 4

Biologics License Application (BLA)